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Office Medic 6.0

by Vectracor, Inc.

Office Medic 6.0 is a Class II device made by Vectracor, Inc., cleared under FDA 510(k) K990266 on 2 Feb 1999 and listed in FDA GUDID since 23 Jan 2017 (UDI-DI 00857175006166), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K990266

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00857175006166 UDI-DI Date23 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK990266 Date2 Feb 1999DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K990266 decided 2 Feb 1999 Active
  • FDA GUDID UDI-DI 00857175006166 listed 23 Jan 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-1315-2012 FDA Not yet classified initiated 16 Feb 2012 on shared 510(k) K990266

    QRS Diagnostic has initiated a recall involving Universal ECG 12 Lead IEC ECG Devices. This recall has been initiated because the chest lead wires on these devices may have been improperly labeled. Incorrect labeling of the lead wires could result in improper lead wire placement on the patient which may result in inaccurate waveforms being displayed to the user and an inaccurate interpretatio

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

3 dated events

  1. Cleared FDA 510(k) K990266
  2. Recall initiated FDA recalls Z-1315-2012
  3. Listed FDA GUDID 00857175006166

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Office Medic
Generic name
Cardiopulmonary physiological parameter analysis software, professional-only
Model / reference
6.0
Primary DI / UDI-DI
00857175006166
510(k) Number
FDA product code
DPS
GMDN term
Cardiopulmonary physiological parameter analysis software, professional-only
Device class
Class II
Regulation number
870.2340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiopulmonary physiological parameter analysis software

Similar devices in this category

Other devices filed under Cardiopulmonary physiological parameter analysis software.

Other devices from Vectracor, Inc.

See all devices from Vectracor, Inc. →

Properties

  • Prescription use
Other properties (14, all answered No)